Effectiveness and Safety of Teriflunomide in Relapsing–Remitting Multiple Sclerosis and Improvements in Quality of Life: Results from the Real-World TERICARE Study
Introduction Teriflunomide is a once-daily oral immunomodulator approved for relapsing forms of multiple sclerosis (MS) or relapsing–remitting multiple sclerosis (RRMS; depending on the local label), based on extensive evidence from clinical trials and a real-world setting on efficacy, tolerability...
Ausführliche Beschreibung
Autor*in: |
Meca-Lallana, José E. [verfasserIn] |
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E-Artikel |
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Englisch |
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2023 |
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Anmerkung: |
© The Author(s) 2023 |
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Übergeordnetes Werk: |
Enthalten in: Neurology and Therapy - Berlin : Springer, 2012, 12(2023), 6 vom: 20. Okt., Seite 2177-2193 |
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Übergeordnetes Werk: |
volume:12 ; year:2023 ; number:6 ; day:20 ; month:10 ; pages:2177-2193 |
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DOI / URN: |
10.1007/s40120-023-00557-7 |
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SPR053658736 |
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245 | 1 | 0 | |a Effectiveness and Safety of Teriflunomide in Relapsing–Remitting Multiple Sclerosis and Improvements in Quality of Life: Results from the Real-World TERICARE Study |
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520 | |a Introduction Teriflunomide is a once-daily oral immunomodulator approved for relapsing forms of multiple sclerosis (MS) or relapsing–remitting multiple sclerosis (RRMS; depending on the local label), based on extensive evidence from clinical trials and a real-world setting on efficacy, tolerability and patient-reported benefits. The TERICARE study assessed the impact of teriflunomide treatment over 2 years on health-related quality of life (HRQoL) and some of the most common and disabling symptoms of MS, such as fatigue and depression. Methods This prospective observational study in Spain included RRMS patients treated with teriflunomide for ≤ 4 weeks. The following patient-reported outcomes (PROs) were collected at baseline and every 6 months for 2 years: the 29-item Multiple Sclerosis Impact Scale version 2 (MSIS-29), the 21-item Modified Fatigue Impact Scale (MFIS-21), the Beck Depression Inventory (BDI-II), the Short Form (SF)-Qualiveen and the Treatment Satisfaction Questionnaire for Medication v1.4 (TSQM). Annualised relapse rate (ARR), disability progression according to the Expanded Disability Status Scale (EDSS), and no evidence of disease activity (NEDA-3) were also assessed. Results A total of 325 patients were analysed. Patients had a mean (SD) age of 43.2 years (10.4), a mean baseline EDSS score of 1.75 (1.5), a mean number of relapses in the past 2 years of 1.5 (0.7), and 64% had received prior disease-modifying therapy (DMT). Patients showed significant improvements in the psychological domain of MSIS-29 from 35.9 (26.6) at baseline to 29.4 (25.5) at 18 months (p = 0.004) and 29.0 (24.6) at 24 months (p = 0.002). Levels of fatigue and depression were also reduced. After 2 years of treatment with teriflunomide, ARR was reduced to 0.17 (95% CI 0.14–0.21) from the baseline of 0.42 (95% CI 0.38–0.48), representing a 60.1% reduction. Mean EDSS scores remained stable during the study, and 79.9% of patients showed no disability progression. 54.7% of patients achieved NEDA-3 in the first 12 months, which increased to 61.4% during months 12–24. Patients reported increased satisfaction with treatment over the course of the study, regardless of whether they were DMT naive or not. Conclusion Teriflunomide improves psychological aspects of HRQoL and maintains low levels of fatigue and depression. Treatment with teriflunomide over 2 years is effective in reducing ARR and disability progression. | ||
650 | 4 | |a Annualised relapse rate |7 (dpeaa)DE-He213 | |
650 | 4 | |a Clinical practice |7 (dpeaa)DE-He213 | |
650 | 4 | |a Disability |7 (dpeaa)DE-He213 | |
650 | 4 | |a Health-related quality of life |7 (dpeaa)DE-He213 | |
650 | 4 | |a Multiple sclerosis |7 (dpeaa)DE-He213 | |
650 | 4 | |a Teriflunomide |7 (dpeaa)DE-He213 | |
700 | 1 | |a Prieto González, José M. |4 aut | |
700 | 1 | |a Caminero Rodríguez, Ana B. |4 aut | |
700 | 1 | |a Olascoaga Urtaza, Javier |4 aut | |
700 | 1 | |a Alonso, Ana M. |4 aut | |
700 | 1 | |a Durán Ferreras, Eduardo |4 aut | |
700 | 1 | |a Espinosa, Raúl |4 aut | |
700 | 1 | |a Dotor, Julio |4 aut | |
700 | 1 | |a Romera, Mercedes |4 aut | |
700 | 1 | |a Ares Luque, Adrián |4 aut | |
700 | 1 | |a Pérez Ruiz, Domingo |4 aut | |
700 | 1 | |a Calles, Carmen |4 aut | |
700 | 1 | |a Hernández, Miguel A. |4 aut | |
700 | 1 | |a Hervás García, Miguel |4 aut | |
700 | 1 | |a Mendoza Rodríguez, Amelia |4 aut | |
700 | 1 | |a Berdei Montero, Yasmina |4 aut | |
700 | 1 | |a Téllez, Nieves |4 aut | |
700 | 1 | |a Herrera Varó, Nicolás |4 aut | |
700 | 1 | |a Sotoca, Javier |4 aut | |
700 | 1 | |a Presas-Rodríguez, Silvia |4 aut | |
700 | 1 | |a Querol Gutierrez, Luis A. |4 aut | |
700 | 1 | |a Hervás Pujol, Mariona |4 aut | |
700 | 1 | |a Batlle Nadal, Jordi |4 aut | |
700 | 1 | |a Martín Ozaeta, Gisela |4 aut | |
700 | 1 | |a Gubieras Lillo, Laura |4 aut | |
700 | 1 | |a Martínez Yélamos, Sergio |4 aut | |
700 | 1 | |a Ramió-Torrentà, Lluís |4 aut | |
700 | 1 | |a Mallada Frechin, Javier |4 aut | |
700 | 1 | |a Belenguer Benavides, Antonio |4 aut | |
700 | 1 | |a Gascón-Giménez, Francisco |4 aut | |
700 | 1 | |a Casanova, Bonaventura |4 aut | |
700 | 1 | |a Landete Pascual, Lamberto |4 aut | |
700 | 1 | |a Berenguer, Leticia |4 aut | |
700 | 1 | |a Navarro, Laura |4 aut | |
700 | 1 | |a Gómez Gutierrez, Montserrat |4 aut | |
700 | 1 | |a Durán, Carmen |4 aut | |
700 | 1 | |a Rodríguez Regal, Ana |4 aut | |
700 | 1 | |a Álvarez, Elena |4 aut | |
700 | 1 | |a García-Estévez, Daniel A. |4 aut | |
700 | 1 | |a López Real, Ana M. |4 aut | |
700 | 1 | |a Llaneza González, Miguel A. |4 aut | |
700 | 1 | |a Marzo Sola, María E. |4 aut | |
700 | 1 | |a Sánchez-Menoyo, José L. |4 aut | |
700 | 1 | |a Oterino, Agustín |4 aut | |
700 | 1 | |a Villaverde González, Ramón |4 aut | |
700 | 1 | |a Castillo-Triviño, Tamara |4 aut | |
700 | 1 | |a Álvarez de Arcaya, Amaya |4 aut | |
700 | 1 | |a Llarena, Cristina |4 aut | |
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10.1007/s40120-023-00557-7 doi (DE-627)SPR053658736 (SPR)s40120-023-00557-7-e DE-627 ger DE-627 rakwb eng Meca-Lallana, José E. verfasserin aut Effectiveness and Safety of Teriflunomide in Relapsing–Remitting Multiple Sclerosis and Improvements in Quality of Life: Results from the Real-World TERICARE Study 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 Introduction Teriflunomide is a once-daily oral immunomodulator approved for relapsing forms of multiple sclerosis (MS) or relapsing–remitting multiple sclerosis (RRMS; depending on the local label), based on extensive evidence from clinical trials and a real-world setting on efficacy, tolerability and patient-reported benefits. The TERICARE study assessed the impact of teriflunomide treatment over 2 years on health-related quality of life (HRQoL) and some of the most common and disabling symptoms of MS, such as fatigue and depression. Methods This prospective observational study in Spain included RRMS patients treated with teriflunomide for ≤ 4 weeks. The following patient-reported outcomes (PROs) were collected at baseline and every 6 months for 2 years: the 29-item Multiple Sclerosis Impact Scale version 2 (MSIS-29), the 21-item Modified Fatigue Impact Scale (MFIS-21), the Beck Depression Inventory (BDI-II), the Short Form (SF)-Qualiveen and the Treatment Satisfaction Questionnaire for Medication v1.4 (TSQM). Annualised relapse rate (ARR), disability progression according to the Expanded Disability Status Scale (EDSS), and no evidence of disease activity (NEDA-3) were also assessed. Results A total of 325 patients were analysed. Patients had a mean (SD) age of 43.2 years (10.4), a mean baseline EDSS score of 1.75 (1.5), a mean number of relapses in the past 2 years of 1.5 (0.7), and 64% had received prior disease-modifying therapy (DMT). Patients showed significant improvements in the psychological domain of MSIS-29 from 35.9 (26.6) at baseline to 29.4 (25.5) at 18 months (p = 0.004) and 29.0 (24.6) at 24 months (p = 0.002). Levels of fatigue and depression were also reduced. After 2 years of treatment with teriflunomide, ARR was reduced to 0.17 (95% CI 0.14–0.21) from the baseline of 0.42 (95% CI 0.38–0.48), representing a 60.1% reduction. Mean EDSS scores remained stable during the study, and 79.9% of patients showed no disability progression. 54.7% of patients achieved NEDA-3 in the first 12 months, which increased to 61.4% during months 12–24. Patients reported increased satisfaction with treatment over the course of the study, regardless of whether they were DMT naive or not. Conclusion Teriflunomide improves psychological aspects of HRQoL and maintains low levels of fatigue and depression. Treatment with teriflunomide over 2 years is effective in reducing ARR and disability progression. Annualised relapse rate (dpeaa)DE-He213 Clinical practice (dpeaa)DE-He213 Disability (dpeaa)DE-He213 Health-related quality of life (dpeaa)DE-He213 Multiple sclerosis (dpeaa)DE-He213 Teriflunomide (dpeaa)DE-He213 Prieto González, José M. aut Caminero Rodríguez, Ana B. aut Olascoaga Urtaza, Javier aut Alonso, Ana M. aut Durán Ferreras, Eduardo aut Espinosa, Raúl aut Dotor, Julio aut Romera, Mercedes aut Ares Luque, Adrián aut Pérez Ruiz, Domingo aut Calles, Carmen aut Hernández, Miguel A. aut Hervás García, Miguel aut Mendoza Rodríguez, Amelia aut Berdei Montero, Yasmina aut Téllez, Nieves aut Herrera Varó, Nicolás aut Sotoca, Javier aut Presas-Rodríguez, Silvia aut Querol Gutierrez, Luis A. aut Hervás Pujol, Mariona aut Batlle Nadal, Jordi aut Martín Ozaeta, Gisela aut Gubieras Lillo, Laura aut Martínez Yélamos, Sergio aut Ramió-Torrentà, Lluís aut Mallada Frechin, Javier aut Belenguer Benavides, Antonio aut Gascón-Giménez, Francisco aut Casanova, Bonaventura aut Landete Pascual, Lamberto aut Berenguer, Leticia aut Navarro, Laura aut Gómez Gutierrez, Montserrat aut Durán, Carmen aut Rodríguez Regal, Ana aut Álvarez, Elena aut García-Estévez, Daniel A. aut López Real, Ana M. aut Llaneza González, Miguel A. aut Marzo Sola, María E. aut Sánchez-Menoyo, José L. aut Oterino, Agustín aut Villaverde González, Ramón aut Castillo-Triviño, Tamara aut Álvarez de Arcaya, Amaya aut Llarena, Cristina aut Enthalten in Neurology and Therapy Berlin : Springer, 2012 12(2023), 6 vom: 20. Okt., Seite 2177-2193 (DE-627)726126209 (DE-600)2682228-3 2193-6536 nnns volume:12 year:2023 number:6 day:20 month:10 pages:2177-2193 https://dx.doi.org/10.1007/s40120-023-00557-7 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2023 6 20 10 2177-2193 |
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10.1007/s40120-023-00557-7 doi (DE-627)SPR053658736 (SPR)s40120-023-00557-7-e DE-627 ger DE-627 rakwb eng Meca-Lallana, José E. verfasserin aut Effectiveness and Safety of Teriflunomide in Relapsing–Remitting Multiple Sclerosis and Improvements in Quality of Life: Results from the Real-World TERICARE Study 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 Introduction Teriflunomide is a once-daily oral immunomodulator approved for relapsing forms of multiple sclerosis (MS) or relapsing–remitting multiple sclerosis (RRMS; depending on the local label), based on extensive evidence from clinical trials and a real-world setting on efficacy, tolerability and patient-reported benefits. The TERICARE study assessed the impact of teriflunomide treatment over 2 years on health-related quality of life (HRQoL) and some of the most common and disabling symptoms of MS, such as fatigue and depression. Methods This prospective observational study in Spain included RRMS patients treated with teriflunomide for ≤ 4 weeks. The following patient-reported outcomes (PROs) were collected at baseline and every 6 months for 2 years: the 29-item Multiple Sclerosis Impact Scale version 2 (MSIS-29), the 21-item Modified Fatigue Impact Scale (MFIS-21), the Beck Depression Inventory (BDI-II), the Short Form (SF)-Qualiveen and the Treatment Satisfaction Questionnaire for Medication v1.4 (TSQM). Annualised relapse rate (ARR), disability progression according to the Expanded Disability Status Scale (EDSS), and no evidence of disease activity (NEDA-3) were also assessed. Results A total of 325 patients were analysed. Patients had a mean (SD) age of 43.2 years (10.4), a mean baseline EDSS score of 1.75 (1.5), a mean number of relapses in the past 2 years of 1.5 (0.7), and 64% had received prior disease-modifying therapy (DMT). Patients showed significant improvements in the psychological domain of MSIS-29 from 35.9 (26.6) at baseline to 29.4 (25.5) at 18 months (p = 0.004) and 29.0 (24.6) at 24 months (p = 0.002). Levels of fatigue and depression were also reduced. After 2 years of treatment with teriflunomide, ARR was reduced to 0.17 (95% CI 0.14–0.21) from the baseline of 0.42 (95% CI 0.38–0.48), representing a 60.1% reduction. Mean EDSS scores remained stable during the study, and 79.9% of patients showed no disability progression. 54.7% of patients achieved NEDA-3 in the first 12 months, which increased to 61.4% during months 12–24. Patients reported increased satisfaction with treatment over the course of the study, regardless of whether they were DMT naive or not. Conclusion Teriflunomide improves psychological aspects of HRQoL and maintains low levels of fatigue and depression. Treatment with teriflunomide over 2 years is effective in reducing ARR and disability progression. Annualised relapse rate (dpeaa)DE-He213 Clinical practice (dpeaa)DE-He213 Disability (dpeaa)DE-He213 Health-related quality of life (dpeaa)DE-He213 Multiple sclerosis (dpeaa)DE-He213 Teriflunomide (dpeaa)DE-He213 Prieto González, José M. aut Caminero Rodríguez, Ana B. aut Olascoaga Urtaza, Javier aut Alonso, Ana M. aut Durán Ferreras, Eduardo aut Espinosa, Raúl aut Dotor, Julio aut Romera, Mercedes aut Ares Luque, Adrián aut Pérez Ruiz, Domingo aut Calles, Carmen aut Hernández, Miguel A. aut Hervás García, Miguel aut Mendoza Rodríguez, Amelia aut Berdei Montero, Yasmina aut Téllez, Nieves aut Herrera Varó, Nicolás aut Sotoca, Javier aut Presas-Rodríguez, Silvia aut Querol Gutierrez, Luis A. aut Hervás Pujol, Mariona aut Batlle Nadal, Jordi aut Martín Ozaeta, Gisela aut Gubieras Lillo, Laura aut Martínez Yélamos, Sergio aut Ramió-Torrentà, Lluís aut Mallada Frechin, Javier aut Belenguer Benavides, Antonio aut Gascón-Giménez, Francisco aut Casanova, Bonaventura aut Landete Pascual, Lamberto aut Berenguer, Leticia aut Navarro, Laura aut Gómez Gutierrez, Montserrat aut Durán, Carmen aut Rodríguez Regal, Ana aut Álvarez, Elena aut García-Estévez, Daniel A. aut López Real, Ana M. aut Llaneza González, Miguel A. aut Marzo Sola, María E. aut Sánchez-Menoyo, José L. aut Oterino, Agustín aut Villaverde González, Ramón aut Castillo-Triviño, Tamara aut Álvarez de Arcaya, Amaya aut Llarena, Cristina aut Enthalten in Neurology and Therapy Berlin : Springer, 2012 12(2023), 6 vom: 20. Okt., Seite 2177-2193 (DE-627)726126209 (DE-600)2682228-3 2193-6536 nnns volume:12 year:2023 number:6 day:20 month:10 pages:2177-2193 https://dx.doi.org/10.1007/s40120-023-00557-7 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2023 6 20 10 2177-2193 |
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10.1007/s40120-023-00557-7 doi (DE-627)SPR053658736 (SPR)s40120-023-00557-7-e DE-627 ger DE-627 rakwb eng Meca-Lallana, José E. verfasserin aut Effectiveness and Safety of Teriflunomide in Relapsing–Remitting Multiple Sclerosis and Improvements in Quality of Life: Results from the Real-World TERICARE Study 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 Introduction Teriflunomide is a once-daily oral immunomodulator approved for relapsing forms of multiple sclerosis (MS) or relapsing–remitting multiple sclerosis (RRMS; depending on the local label), based on extensive evidence from clinical trials and a real-world setting on efficacy, tolerability and patient-reported benefits. The TERICARE study assessed the impact of teriflunomide treatment over 2 years on health-related quality of life (HRQoL) and some of the most common and disabling symptoms of MS, such as fatigue and depression. Methods This prospective observational study in Spain included RRMS patients treated with teriflunomide for ≤ 4 weeks. The following patient-reported outcomes (PROs) were collected at baseline and every 6 months for 2 years: the 29-item Multiple Sclerosis Impact Scale version 2 (MSIS-29), the 21-item Modified Fatigue Impact Scale (MFIS-21), the Beck Depression Inventory (BDI-II), the Short Form (SF)-Qualiveen and the Treatment Satisfaction Questionnaire for Medication v1.4 (TSQM). Annualised relapse rate (ARR), disability progression according to the Expanded Disability Status Scale (EDSS), and no evidence of disease activity (NEDA-3) were also assessed. Results A total of 325 patients were analysed. Patients had a mean (SD) age of 43.2 years (10.4), a mean baseline EDSS score of 1.75 (1.5), a mean number of relapses in the past 2 years of 1.5 (0.7), and 64% had received prior disease-modifying therapy (DMT). Patients showed significant improvements in the psychological domain of MSIS-29 from 35.9 (26.6) at baseline to 29.4 (25.5) at 18 months (p = 0.004) and 29.0 (24.6) at 24 months (p = 0.002). Levels of fatigue and depression were also reduced. After 2 years of treatment with teriflunomide, ARR was reduced to 0.17 (95% CI 0.14–0.21) from the baseline of 0.42 (95% CI 0.38–0.48), representing a 60.1% reduction. Mean EDSS scores remained stable during the study, and 79.9% of patients showed no disability progression. 54.7% of patients achieved NEDA-3 in the first 12 months, which increased to 61.4% during months 12–24. Patients reported increased satisfaction with treatment over the course of the study, regardless of whether they were DMT naive or not. Conclusion Teriflunomide improves psychological aspects of HRQoL and maintains low levels of fatigue and depression. Treatment with teriflunomide over 2 years is effective in reducing ARR and disability progression. Annualised relapse rate (dpeaa)DE-He213 Clinical practice (dpeaa)DE-He213 Disability (dpeaa)DE-He213 Health-related quality of life (dpeaa)DE-He213 Multiple sclerosis (dpeaa)DE-He213 Teriflunomide (dpeaa)DE-He213 Prieto González, José M. aut Caminero Rodríguez, Ana B. aut Olascoaga Urtaza, Javier aut Alonso, Ana M. aut Durán Ferreras, Eduardo aut Espinosa, Raúl aut Dotor, Julio aut Romera, Mercedes aut Ares Luque, Adrián aut Pérez Ruiz, Domingo aut Calles, Carmen aut Hernández, Miguel A. aut Hervás García, Miguel aut Mendoza Rodríguez, Amelia aut Berdei Montero, Yasmina aut Téllez, Nieves aut Herrera Varó, Nicolás aut Sotoca, Javier aut Presas-Rodríguez, Silvia aut Querol Gutierrez, Luis A. aut Hervás Pujol, Mariona aut Batlle Nadal, Jordi aut Martín Ozaeta, Gisela aut Gubieras Lillo, Laura aut Martínez Yélamos, Sergio aut Ramió-Torrentà, Lluís aut Mallada Frechin, Javier aut Belenguer Benavides, Antonio aut Gascón-Giménez, Francisco aut Casanova, Bonaventura aut Landete Pascual, Lamberto aut Berenguer, Leticia aut Navarro, Laura aut Gómez Gutierrez, Montserrat aut Durán, Carmen aut Rodríguez Regal, Ana aut Álvarez, Elena aut García-Estévez, Daniel A. aut López Real, Ana M. aut Llaneza González, Miguel A. aut Marzo Sola, María E. aut Sánchez-Menoyo, José L. aut Oterino, Agustín aut Villaverde González, Ramón aut Castillo-Triviño, Tamara aut Álvarez de Arcaya, Amaya aut Llarena, Cristina aut Enthalten in Neurology and Therapy Berlin : Springer, 2012 12(2023), 6 vom: 20. Okt., Seite 2177-2193 (DE-627)726126209 (DE-600)2682228-3 2193-6536 nnns volume:12 year:2023 number:6 day:20 month:10 pages:2177-2193 https://dx.doi.org/10.1007/s40120-023-00557-7 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2023 6 20 10 2177-2193 |
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10.1007/s40120-023-00557-7 doi (DE-627)SPR053658736 (SPR)s40120-023-00557-7-e DE-627 ger DE-627 rakwb eng Meca-Lallana, José E. verfasserin aut Effectiveness and Safety of Teriflunomide in Relapsing–Remitting Multiple Sclerosis and Improvements in Quality of Life: Results from the Real-World TERICARE Study 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 Introduction Teriflunomide is a once-daily oral immunomodulator approved for relapsing forms of multiple sclerosis (MS) or relapsing–remitting multiple sclerosis (RRMS; depending on the local label), based on extensive evidence from clinical trials and a real-world setting on efficacy, tolerability and patient-reported benefits. The TERICARE study assessed the impact of teriflunomide treatment over 2 years on health-related quality of life (HRQoL) and some of the most common and disabling symptoms of MS, such as fatigue and depression. Methods This prospective observational study in Spain included RRMS patients treated with teriflunomide for ≤ 4 weeks. The following patient-reported outcomes (PROs) were collected at baseline and every 6 months for 2 years: the 29-item Multiple Sclerosis Impact Scale version 2 (MSIS-29), the 21-item Modified Fatigue Impact Scale (MFIS-21), the Beck Depression Inventory (BDI-II), the Short Form (SF)-Qualiveen and the Treatment Satisfaction Questionnaire for Medication v1.4 (TSQM). Annualised relapse rate (ARR), disability progression according to the Expanded Disability Status Scale (EDSS), and no evidence of disease activity (NEDA-3) were also assessed. Results A total of 325 patients were analysed. Patients had a mean (SD) age of 43.2 years (10.4), a mean baseline EDSS score of 1.75 (1.5), a mean number of relapses in the past 2 years of 1.5 (0.7), and 64% had received prior disease-modifying therapy (DMT). Patients showed significant improvements in the psychological domain of MSIS-29 from 35.9 (26.6) at baseline to 29.4 (25.5) at 18 months (p = 0.004) and 29.0 (24.6) at 24 months (p = 0.002). Levels of fatigue and depression were also reduced. After 2 years of treatment with teriflunomide, ARR was reduced to 0.17 (95% CI 0.14–0.21) from the baseline of 0.42 (95% CI 0.38–0.48), representing a 60.1% reduction. Mean EDSS scores remained stable during the study, and 79.9% of patients showed no disability progression. 54.7% of patients achieved NEDA-3 in the first 12 months, which increased to 61.4% during months 12–24. Patients reported increased satisfaction with treatment over the course of the study, regardless of whether they were DMT naive or not. Conclusion Teriflunomide improves psychological aspects of HRQoL and maintains low levels of fatigue and depression. Treatment with teriflunomide over 2 years is effective in reducing ARR and disability progression. Annualised relapse rate (dpeaa)DE-He213 Clinical practice (dpeaa)DE-He213 Disability (dpeaa)DE-He213 Health-related quality of life (dpeaa)DE-He213 Multiple sclerosis (dpeaa)DE-He213 Teriflunomide (dpeaa)DE-He213 Prieto González, José M. aut Caminero Rodríguez, Ana B. aut Olascoaga Urtaza, Javier aut Alonso, Ana M. aut Durán Ferreras, Eduardo aut Espinosa, Raúl aut Dotor, Julio aut Romera, Mercedes aut Ares Luque, Adrián aut Pérez Ruiz, Domingo aut Calles, Carmen aut Hernández, Miguel A. aut Hervás García, Miguel aut Mendoza Rodríguez, Amelia aut Berdei Montero, Yasmina aut Téllez, Nieves aut Herrera Varó, Nicolás aut Sotoca, Javier aut Presas-Rodríguez, Silvia aut Querol Gutierrez, Luis A. aut Hervás Pujol, Mariona aut Batlle Nadal, Jordi aut Martín Ozaeta, Gisela aut Gubieras Lillo, Laura aut Martínez Yélamos, Sergio aut Ramió-Torrentà, Lluís aut Mallada Frechin, Javier aut Belenguer Benavides, Antonio aut Gascón-Giménez, Francisco aut Casanova, Bonaventura aut Landete Pascual, Lamberto aut Berenguer, Leticia aut Navarro, Laura aut Gómez Gutierrez, Montserrat aut Durán, Carmen aut Rodríguez Regal, Ana aut Álvarez, Elena aut García-Estévez, Daniel A. aut López Real, Ana M. aut Llaneza González, Miguel A. aut Marzo Sola, María E. aut Sánchez-Menoyo, José L. aut Oterino, Agustín aut Villaverde González, Ramón aut Castillo-Triviño, Tamara aut Álvarez de Arcaya, Amaya aut Llarena, Cristina aut Enthalten in Neurology and Therapy Berlin : Springer, 2012 12(2023), 6 vom: 20. Okt., Seite 2177-2193 (DE-627)726126209 (DE-600)2682228-3 2193-6536 nnns volume:12 year:2023 number:6 day:20 month:10 pages:2177-2193 https://dx.doi.org/10.1007/s40120-023-00557-7 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2023 6 20 10 2177-2193 |
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10.1007/s40120-023-00557-7 doi (DE-627)SPR053658736 (SPR)s40120-023-00557-7-e DE-627 ger DE-627 rakwb eng Meca-Lallana, José E. verfasserin aut Effectiveness and Safety of Teriflunomide in Relapsing–Remitting Multiple Sclerosis and Improvements in Quality of Life: Results from the Real-World TERICARE Study 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 Introduction Teriflunomide is a once-daily oral immunomodulator approved for relapsing forms of multiple sclerosis (MS) or relapsing–remitting multiple sclerosis (RRMS; depending on the local label), based on extensive evidence from clinical trials and a real-world setting on efficacy, tolerability and patient-reported benefits. The TERICARE study assessed the impact of teriflunomide treatment over 2 years on health-related quality of life (HRQoL) and some of the most common and disabling symptoms of MS, such as fatigue and depression. Methods This prospective observational study in Spain included RRMS patients treated with teriflunomide for ≤ 4 weeks. The following patient-reported outcomes (PROs) were collected at baseline and every 6 months for 2 years: the 29-item Multiple Sclerosis Impact Scale version 2 (MSIS-29), the 21-item Modified Fatigue Impact Scale (MFIS-21), the Beck Depression Inventory (BDI-II), the Short Form (SF)-Qualiveen and the Treatment Satisfaction Questionnaire for Medication v1.4 (TSQM). Annualised relapse rate (ARR), disability progression according to the Expanded Disability Status Scale (EDSS), and no evidence of disease activity (NEDA-3) were also assessed. Results A total of 325 patients were analysed. Patients had a mean (SD) age of 43.2 years (10.4), a mean baseline EDSS score of 1.75 (1.5), a mean number of relapses in the past 2 years of 1.5 (0.7), and 64% had received prior disease-modifying therapy (DMT). Patients showed significant improvements in the psychological domain of MSIS-29 from 35.9 (26.6) at baseline to 29.4 (25.5) at 18 months (p = 0.004) and 29.0 (24.6) at 24 months (p = 0.002). Levels of fatigue and depression were also reduced. After 2 years of treatment with teriflunomide, ARR was reduced to 0.17 (95% CI 0.14–0.21) from the baseline of 0.42 (95% CI 0.38–0.48), representing a 60.1% reduction. Mean EDSS scores remained stable during the study, and 79.9% of patients showed no disability progression. 54.7% of patients achieved NEDA-3 in the first 12 months, which increased to 61.4% during months 12–24. Patients reported increased satisfaction with treatment over the course of the study, regardless of whether they were DMT naive or not. Conclusion Teriflunomide improves psychological aspects of HRQoL and maintains low levels of fatigue and depression. Treatment with teriflunomide over 2 years is effective in reducing ARR and disability progression. Annualised relapse rate (dpeaa)DE-He213 Clinical practice (dpeaa)DE-He213 Disability (dpeaa)DE-He213 Health-related quality of life (dpeaa)DE-He213 Multiple sclerosis (dpeaa)DE-He213 Teriflunomide (dpeaa)DE-He213 Prieto González, José M. aut Caminero Rodríguez, Ana B. aut Olascoaga Urtaza, Javier aut Alonso, Ana M. aut Durán Ferreras, Eduardo aut Espinosa, Raúl aut Dotor, Julio aut Romera, Mercedes aut Ares Luque, Adrián aut Pérez Ruiz, Domingo aut Calles, Carmen aut Hernández, Miguel A. aut Hervás García, Miguel aut Mendoza Rodríguez, Amelia aut Berdei Montero, Yasmina aut Téllez, Nieves aut Herrera Varó, Nicolás aut Sotoca, Javier aut Presas-Rodríguez, Silvia aut Querol Gutierrez, Luis A. aut Hervás Pujol, Mariona aut Batlle Nadal, Jordi aut Martín Ozaeta, Gisela aut Gubieras Lillo, Laura aut Martínez Yélamos, Sergio aut Ramió-Torrentà, Lluís aut Mallada Frechin, Javier aut Belenguer Benavides, Antonio aut Gascón-Giménez, Francisco aut Casanova, Bonaventura aut Landete Pascual, Lamberto aut Berenguer, Leticia aut Navarro, Laura aut Gómez Gutierrez, Montserrat aut Durán, Carmen aut Rodríguez Regal, Ana aut Álvarez, Elena aut García-Estévez, Daniel A. aut López Real, Ana M. aut Llaneza González, Miguel A. aut Marzo Sola, María E. aut Sánchez-Menoyo, José L. aut Oterino, Agustín aut Villaverde González, Ramón aut Castillo-Triviño, Tamara aut Álvarez de Arcaya, Amaya aut Llarena, Cristina aut Enthalten in Neurology and Therapy Berlin : Springer, 2012 12(2023), 6 vom: 20. Okt., Seite 2177-2193 (DE-627)726126209 (DE-600)2682228-3 2193-6536 nnns volume:12 year:2023 number:6 day:20 month:10 pages:2177-2193 https://dx.doi.org/10.1007/s40120-023-00557-7 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2023 6 20 10 2177-2193 |
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Meca-Lallana, José E. @@aut@@ Prieto González, José M. @@aut@@ Caminero Rodríguez, Ana B. @@aut@@ Olascoaga Urtaza, Javier @@aut@@ Alonso, Ana M. @@aut@@ Durán Ferreras, Eduardo @@aut@@ Espinosa, Raúl @@aut@@ Dotor, Julio @@aut@@ Romera, Mercedes @@aut@@ Ares Luque, Adrián @@aut@@ Pérez Ruiz, Domingo @@aut@@ Calles, Carmen @@aut@@ Hernández, Miguel A. @@aut@@ Hervás García, Miguel @@aut@@ Mendoza Rodríguez, Amelia @@aut@@ Berdei Montero, Yasmina @@aut@@ Téllez, Nieves @@aut@@ Herrera Varó, Nicolás @@aut@@ Sotoca, Javier @@aut@@ Presas-Rodríguez, Silvia @@aut@@ Querol Gutierrez, Luis A. @@aut@@ Hervás Pujol, Mariona @@aut@@ Batlle Nadal, Jordi @@aut@@ Martín Ozaeta, Gisela @@aut@@ Gubieras Lillo, Laura @@aut@@ Martínez Yélamos, Sergio @@aut@@ Ramió-Torrentà, Lluís @@aut@@ Mallada Frechin, Javier @@aut@@ Belenguer Benavides, Antonio @@aut@@ Gascón-Giménez, Francisco @@aut@@ Casanova, Bonaventura @@aut@@ Landete Pascual, Lamberto @@aut@@ Berenguer, Leticia @@aut@@ Navarro, Laura @@aut@@ Gómez Gutierrez, Montserrat @@aut@@ Durán, Carmen @@aut@@ Rodríguez Regal, Ana @@aut@@ Álvarez, Elena @@aut@@ García-Estévez, Daniel A. @@aut@@ López Real, Ana M. @@aut@@ Llaneza González, Miguel A. @@aut@@ Marzo Sola, María E. @@aut@@ Sánchez-Menoyo, José L. @@aut@@ Oterino, Agustín @@aut@@ Villaverde González, Ramón @@aut@@ Castillo-Triviño, Tamara @@aut@@ Álvarez de Arcaya, Amaya @@aut@@ Llarena, Cristina @@aut@@ |
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The TERICARE study assessed the impact of teriflunomide treatment over 2 years on health-related quality of life (HRQoL) and some of the most common and disabling symptoms of MS, such as fatigue and depression. Methods This prospective observational study in Spain included RRMS patients treated with teriflunomide for ≤ 4 weeks. The following patient-reported outcomes (PROs) were collected at baseline and every 6 months for 2 years: the 29-item Multiple Sclerosis Impact Scale version 2 (MSIS-29), the 21-item Modified Fatigue Impact Scale (MFIS-21), the Beck Depression Inventory (BDI-II), the Short Form (SF)-Qualiveen and the Treatment Satisfaction Questionnaire for Medication v1.4 (TSQM). Annualised relapse rate (ARR), disability progression according to the Expanded Disability Status Scale (EDSS), and no evidence of disease activity (NEDA-3) were also assessed. Results A total of 325 patients were analysed. Patients had a mean (SD) age of 43.2 years (10.4), a mean baseline EDSS score of 1.75 (1.5), a mean number of relapses in the past 2 years of 1.5 (0.7), and 64% had received prior disease-modifying therapy (DMT). Patients showed significant improvements in the psychological domain of MSIS-29 from 35.9 (26.6) at baseline to 29.4 (25.5) at 18 months (p = 0.004) and 29.0 (24.6) at 24 months (p = 0.002). Levels of fatigue and depression were also reduced. After 2 years of treatment with teriflunomide, ARR was reduced to 0.17 (95% CI 0.14–0.21) from the baseline of 0.42 (95% CI 0.38–0.48), representing a 60.1% reduction. Mean EDSS scores remained stable during the study, and 79.9% of patients showed no disability progression. 54.7% of patients achieved NEDA-3 in the first 12 months, which increased to 61.4% during months 12–24. Patients reported increased satisfaction with treatment over the course of the study, regardless of whether they were DMT naive or not. 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Meca-Lallana, José E. misc Annualised relapse rate misc Clinical practice misc Disability misc Health-related quality of life misc Multiple sclerosis misc Teriflunomide Effectiveness and Safety of Teriflunomide in Relapsing–Remitting Multiple Sclerosis and Improvements in Quality of Life: Results from the Real-World TERICARE Study |
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Effectiveness and Safety of Teriflunomide in Relapsing–Remitting Multiple Sclerosis and Improvements in Quality of Life: Results from the Real-World TERICARE Study Annualised relapse rate (dpeaa)DE-He213 Clinical practice (dpeaa)DE-He213 Disability (dpeaa)DE-He213 Health-related quality of life (dpeaa)DE-He213 Multiple sclerosis (dpeaa)DE-He213 Teriflunomide (dpeaa)DE-He213 |
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Effectiveness and Safety of Teriflunomide in Relapsing–Remitting Multiple Sclerosis and Improvements in Quality of Life: Results from the Real-World TERICARE Study |
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Effectiveness and Safety of Teriflunomide in Relapsing–Remitting Multiple Sclerosis and Improvements in Quality of Life: Results from the Real-World TERICARE Study |
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Meca-Lallana, José E. Prieto González, José M. Caminero Rodríguez, Ana B. Olascoaga Urtaza, Javier Alonso, Ana M. Durán Ferreras, Eduardo Espinosa, Raúl Dotor, Julio Romera, Mercedes Ares Luque, Adrián Pérez Ruiz, Domingo Calles, Carmen Hernández, Miguel A. Hervás García, Miguel Mendoza Rodríguez, Amelia Berdei Montero, Yasmina Téllez, Nieves Herrera Varó, Nicolás Sotoca, Javier Presas-Rodríguez, Silvia Querol Gutierrez, Luis A. Hervás Pujol, Mariona Batlle Nadal, Jordi Martín Ozaeta, Gisela Gubieras Lillo, Laura Martínez Yélamos, Sergio Ramió-Torrentà, Lluís Mallada Frechin, Javier Belenguer Benavides, Antonio Gascón-Giménez, Francisco Casanova, Bonaventura Landete Pascual, Lamberto Berenguer, Leticia Navarro, Laura Gómez Gutierrez, Montserrat Durán, Carmen Rodríguez Regal, Ana Álvarez, Elena García-Estévez, Daniel A. López Real, Ana M. Llaneza González, Miguel A. Marzo Sola, María E. Sánchez-Menoyo, José L. Oterino, Agustín Villaverde González, Ramón Castillo-Triviño, Tamara Álvarez de Arcaya, Amaya Llarena, Cristina |
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10.1007/s40120-023-00557-7 |
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effectiveness and safety of teriflunomide in relapsing–remitting multiple sclerosis and improvements in quality of life: results from the real-world tericare study |
title_auth |
Effectiveness and Safety of Teriflunomide in Relapsing–Remitting Multiple Sclerosis and Improvements in Quality of Life: Results from the Real-World TERICARE Study |
abstract |
Introduction Teriflunomide is a once-daily oral immunomodulator approved for relapsing forms of multiple sclerosis (MS) or relapsing–remitting multiple sclerosis (RRMS; depending on the local label), based on extensive evidence from clinical trials and a real-world setting on efficacy, tolerability and patient-reported benefits. The TERICARE study assessed the impact of teriflunomide treatment over 2 years on health-related quality of life (HRQoL) and some of the most common and disabling symptoms of MS, such as fatigue and depression. Methods This prospective observational study in Spain included RRMS patients treated with teriflunomide for ≤ 4 weeks. The following patient-reported outcomes (PROs) were collected at baseline and every 6 months for 2 years: the 29-item Multiple Sclerosis Impact Scale version 2 (MSIS-29), the 21-item Modified Fatigue Impact Scale (MFIS-21), the Beck Depression Inventory (BDI-II), the Short Form (SF)-Qualiveen and the Treatment Satisfaction Questionnaire for Medication v1.4 (TSQM). Annualised relapse rate (ARR), disability progression according to the Expanded Disability Status Scale (EDSS), and no evidence of disease activity (NEDA-3) were also assessed. Results A total of 325 patients were analysed. Patients had a mean (SD) age of 43.2 years (10.4), a mean baseline EDSS score of 1.75 (1.5), a mean number of relapses in the past 2 years of 1.5 (0.7), and 64% had received prior disease-modifying therapy (DMT). Patients showed significant improvements in the psychological domain of MSIS-29 from 35.9 (26.6) at baseline to 29.4 (25.5) at 18 months (p = 0.004) and 29.0 (24.6) at 24 months (p = 0.002). Levels of fatigue and depression were also reduced. After 2 years of treatment with teriflunomide, ARR was reduced to 0.17 (95% CI 0.14–0.21) from the baseline of 0.42 (95% CI 0.38–0.48), representing a 60.1% reduction. Mean EDSS scores remained stable during the study, and 79.9% of patients showed no disability progression. 54.7% of patients achieved NEDA-3 in the first 12 months, which increased to 61.4% during months 12–24. Patients reported increased satisfaction with treatment over the course of the study, regardless of whether they were DMT naive or not. Conclusion Teriflunomide improves psychological aspects of HRQoL and maintains low levels of fatigue and depression. Treatment with teriflunomide over 2 years is effective in reducing ARR and disability progression. © The Author(s) 2023 |
abstractGer |
Introduction Teriflunomide is a once-daily oral immunomodulator approved for relapsing forms of multiple sclerosis (MS) or relapsing–remitting multiple sclerosis (RRMS; depending on the local label), based on extensive evidence from clinical trials and a real-world setting on efficacy, tolerability and patient-reported benefits. The TERICARE study assessed the impact of teriflunomide treatment over 2 years on health-related quality of life (HRQoL) and some of the most common and disabling symptoms of MS, such as fatigue and depression. Methods This prospective observational study in Spain included RRMS patients treated with teriflunomide for ≤ 4 weeks. The following patient-reported outcomes (PROs) were collected at baseline and every 6 months for 2 years: the 29-item Multiple Sclerosis Impact Scale version 2 (MSIS-29), the 21-item Modified Fatigue Impact Scale (MFIS-21), the Beck Depression Inventory (BDI-II), the Short Form (SF)-Qualiveen and the Treatment Satisfaction Questionnaire for Medication v1.4 (TSQM). Annualised relapse rate (ARR), disability progression according to the Expanded Disability Status Scale (EDSS), and no evidence of disease activity (NEDA-3) were also assessed. Results A total of 325 patients were analysed. Patients had a mean (SD) age of 43.2 years (10.4), a mean baseline EDSS score of 1.75 (1.5), a mean number of relapses in the past 2 years of 1.5 (0.7), and 64% had received prior disease-modifying therapy (DMT). Patients showed significant improvements in the psychological domain of MSIS-29 from 35.9 (26.6) at baseline to 29.4 (25.5) at 18 months (p = 0.004) and 29.0 (24.6) at 24 months (p = 0.002). Levels of fatigue and depression were also reduced. After 2 years of treatment with teriflunomide, ARR was reduced to 0.17 (95% CI 0.14–0.21) from the baseline of 0.42 (95% CI 0.38–0.48), representing a 60.1% reduction. Mean EDSS scores remained stable during the study, and 79.9% of patients showed no disability progression. 54.7% of patients achieved NEDA-3 in the first 12 months, which increased to 61.4% during months 12–24. Patients reported increased satisfaction with treatment over the course of the study, regardless of whether they were DMT naive or not. Conclusion Teriflunomide improves psychological aspects of HRQoL and maintains low levels of fatigue and depression. Treatment with teriflunomide over 2 years is effective in reducing ARR and disability progression. © The Author(s) 2023 |
abstract_unstemmed |
Introduction Teriflunomide is a once-daily oral immunomodulator approved for relapsing forms of multiple sclerosis (MS) or relapsing–remitting multiple sclerosis (RRMS; depending on the local label), based on extensive evidence from clinical trials and a real-world setting on efficacy, tolerability and patient-reported benefits. The TERICARE study assessed the impact of teriflunomide treatment over 2 years on health-related quality of life (HRQoL) and some of the most common and disabling symptoms of MS, such as fatigue and depression. Methods This prospective observational study in Spain included RRMS patients treated with teriflunomide for ≤ 4 weeks. The following patient-reported outcomes (PROs) were collected at baseline and every 6 months for 2 years: the 29-item Multiple Sclerosis Impact Scale version 2 (MSIS-29), the 21-item Modified Fatigue Impact Scale (MFIS-21), the Beck Depression Inventory (BDI-II), the Short Form (SF)-Qualiveen and the Treatment Satisfaction Questionnaire for Medication v1.4 (TSQM). Annualised relapse rate (ARR), disability progression according to the Expanded Disability Status Scale (EDSS), and no evidence of disease activity (NEDA-3) were also assessed. Results A total of 325 patients were analysed. Patients had a mean (SD) age of 43.2 years (10.4), a mean baseline EDSS score of 1.75 (1.5), a mean number of relapses in the past 2 years of 1.5 (0.7), and 64% had received prior disease-modifying therapy (DMT). Patients showed significant improvements in the psychological domain of MSIS-29 from 35.9 (26.6) at baseline to 29.4 (25.5) at 18 months (p = 0.004) and 29.0 (24.6) at 24 months (p = 0.002). Levels of fatigue and depression were also reduced. After 2 years of treatment with teriflunomide, ARR was reduced to 0.17 (95% CI 0.14–0.21) from the baseline of 0.42 (95% CI 0.38–0.48), representing a 60.1% reduction. Mean EDSS scores remained stable during the study, and 79.9% of patients showed no disability progression. 54.7% of patients achieved NEDA-3 in the first 12 months, which increased to 61.4% during months 12–24. Patients reported increased satisfaction with treatment over the course of the study, regardless of whether they were DMT naive or not. Conclusion Teriflunomide improves psychological aspects of HRQoL and maintains low levels of fatigue and depression. Treatment with teriflunomide over 2 years is effective in reducing ARR and disability progression. © The Author(s) 2023 |
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Effectiveness and Safety of Teriflunomide in Relapsing–Remitting Multiple Sclerosis and Improvements in Quality of Life: Results from the Real-World TERICARE Study |
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Prieto González, José M. Caminero Rodríguez, Ana B. Olascoaga Urtaza, Javier Alonso, Ana M. Durán Ferreras, Eduardo Espinosa, Raúl Dotor, Julio Romera, Mercedes Ares Luque, Adrián Pérez Ruiz, Domingo Calles, Carmen Hernández, Miguel A. Hervás García, Miguel Mendoza Rodríguez, Amelia Berdei Montero, Yasmina Téllez, Nieves Herrera Varó, Nicolás Sotoca, Javier Presas-Rodríguez, Silvia Querol Gutierrez, Luis A. Hervás Pujol, Mariona Batlle Nadal, Jordi Martín Ozaeta, Gisela Gubieras Lillo, Laura Martínez Yélamos, Sergio Ramió-Torrentà, Lluís Mallada Frechin, Javier Belenguer Benavides, Antonio Gascón-Giménez, Francisco Casanova, Bonaventura Landete Pascual, Lamberto Berenguer, Leticia Navarro, Laura Gómez Gutierrez, Montserrat Durán, Carmen Rodríguez Regal, Ana Álvarez, Elena García-Estévez, Daniel A. López Real, Ana M. Llaneza González, Miguel A. Marzo Sola, María E. Sánchez-Menoyo, José L. Oterino, Agustín Villaverde González, Ramón Castillo-Triviño, Tamara Álvarez de Arcaya, Amaya Llarena, Cristina |
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Prieto González, José M. Caminero Rodríguez, Ana B. Olascoaga Urtaza, Javier Alonso, Ana M. Durán Ferreras, Eduardo Espinosa, Raúl Dotor, Julio Romera, Mercedes Ares Luque, Adrián Pérez Ruiz, Domingo Calles, Carmen Hernández, Miguel A. Hervás García, Miguel Mendoza Rodríguez, Amelia Berdei Montero, Yasmina Téllez, Nieves Herrera Varó, Nicolás Sotoca, Javier Presas-Rodríguez, Silvia Querol Gutierrez, Luis A. Hervás Pujol, Mariona Batlle Nadal, Jordi Martín Ozaeta, Gisela Gubieras Lillo, Laura Martínez Yélamos, Sergio Ramió-Torrentà, Lluís Mallada Frechin, Javier Belenguer Benavides, Antonio Gascón-Giménez, Francisco Casanova, Bonaventura Landete Pascual, Lamberto Berenguer, Leticia Navarro, Laura Gómez Gutierrez, Montserrat Durán, Carmen Rodríguez Regal, Ana Álvarez, Elena García-Estévez, Daniel A. López Real, Ana M. Llaneza González, Miguel A. Marzo Sola, María E. Sánchez-Menoyo, José L. Oterino, Agustín Villaverde González, Ramón Castillo-Triviño, Tamara Álvarez de Arcaya, Amaya Llarena, Cristina |
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The TERICARE study assessed the impact of teriflunomide treatment over 2 years on health-related quality of life (HRQoL) and some of the most common and disabling symptoms of MS, such as fatigue and depression. Methods This prospective observational study in Spain included RRMS patients treated with teriflunomide for ≤ 4 weeks. The following patient-reported outcomes (PROs) were collected at baseline and every 6 months for 2 years: the 29-item Multiple Sclerosis Impact Scale version 2 (MSIS-29), the 21-item Modified Fatigue Impact Scale (MFIS-21), the Beck Depression Inventory (BDI-II), the Short Form (SF)-Qualiveen and the Treatment Satisfaction Questionnaire for Medication v1.4 (TSQM). Annualised relapse rate (ARR), disability progression according to the Expanded Disability Status Scale (EDSS), and no evidence of disease activity (NEDA-3) were also assessed. Results A total of 325 patients were analysed. Patients had a mean (SD) age of 43.2 years (10.4), a mean baseline EDSS score of 1.75 (1.5), a mean number of relapses in the past 2 years of 1.5 (0.7), and 64% had received prior disease-modifying therapy (DMT). Patients showed significant improvements in the psychological domain of MSIS-29 from 35.9 (26.6) at baseline to 29.4 (25.5) at 18 months (p = 0.004) and 29.0 (24.6) at 24 months (p = 0.002). Levels of fatigue and depression were also reduced. After 2 years of treatment with teriflunomide, ARR was reduced to 0.17 (95% CI 0.14–0.21) from the baseline of 0.42 (95% CI 0.38–0.48), representing a 60.1% reduction. Mean EDSS scores remained stable during the study, and 79.9% of patients showed no disability progression. 54.7% of patients achieved NEDA-3 in the first 12 months, which increased to 61.4% during months 12–24. Patients reported increased satisfaction with treatment over the course of the study, regardless of whether they were DMT naive or not. 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